Urinary Catheters With Protective Tip

ABSTRACT

A protective catheter tip has a generally tubular body portion defining an interior cavity. The proximal end of a urinary catheter is at least partially received within the protective tip, with the protective tip being retained on the urinary catheter without the need for a sleeve connecting the protective tip and the catheter. The protective tip may include a projection received within a draining hole or eye at the proximal end of the catheter to retain the protective tip on the catheter. The protective tip may instead include one or more projections that apply a frictional force to an outer surface of the catheter to retain the protective tip on the catheter. The protective tip may instead be retained on the catheter by a tether extending between the protective tip and a distal end of the catheter. The protective tip may also be provided in two pieces.

RELATED APPLICATION

This application claims the benefit of and priority of U.S.Non-Provisional patent application Ser. No. 13/803,139, filed Mar. 14,2013, which is incorporated herein by reference.

DESCRIPTION

1. Technical Field

The present disclosure generally relates to urinary catheters. Moreparticularly, the present disclosure relates to urinary catheterassemblies having a protective tip.

2. Background

Catheters are used to treat many different types of medical conditionsand typically include an elongated shaft that is inserted into andthrough a passageway or lumen of the body. Catheters, and in particularintermittent catheters, are commonly used by those who suffer fromvarious abnormalities of the urinary system, such as urinaryincontinence. With the advent of intermittent catheters, individualswith urinary system abnormalities can self-insert and self-removeintermittent catheters several times a day. Such catheters typicallyinclude a shaft that is sufficiently flexible to navigate the curves ofthe urethra (especially catheters intended for male users), yet rigidenough to be pushed through the urethra without collapsing or “snaking”before an end of the catheter reaches the bladder.

An exemplary male urinary catheter C according to conventional design isshown in FIG. 1. A proximal end P of the catheter C includes drainingholes or eyes E for the drainage of bodily fluids therethrough and intoan internal conduit or lumen of the catheter C. The distal end D of thecatheter may include a connecting member F, such as a funnel, forfluidly connecting the catheter C to a collection container, such as acollection bag into which urine drains.

The catheter C may be used in combination with a protective tip or capor cover T (FIG. 2) that substantially encircles at least a portion ofthe proximal end P. FIG. 3 shows the proximal end P of the catheter Creceived within the protective tip T. The protective tip T has agenerally tubular body portion B defining an interior cavity V (FIG. 3)that extends between an open end O and an access end A. The open end Ois the end of the protective tip T into which the catheter C is inserted(in a direction toward the access end A). The access end A is movablebetween a generally closed condition when the proximal end P of thecatheter C is positioned within the protective tip T (illustrated) and agenerally open condition when the catheter C is advanced proximally(i.e., in a right-to-left direction in the orientation of FIG. 3) so asto pass through the access end A for advancement into and through theurethra. As shown in FIGS. 2 and 3, the access end A of the protectivetip T may include one or more slits S, according to conventional design,that allow it to move between the generally closed and generally openconditions.

The protective tip T serves to isolate the proximal end P of thecatheter C (including the eyes E) from the outside environment (e.g.,from touch contamination whereby bacteria present on a user's handsmight be transferred to the proximal end P of the catheter C) prior toinsertion into the urethra and from the relatively high concentration ofbacteria typically present in the distal urethra. By isolating theproximal end P of the catheter C from the outside environment, thesterility of the proximal end P may be maintained, thereby preventingbacteria from attaching to the proximal end P and being transferred tothe urinary system. As shown in FIG. 3, the outer diameter of thecatheter C may be smaller than the inner diameter of the protective tipT, such that there is a generally annular gap separating the catheter Cand the protective tip T. Accordingly, to associate the protective tip Tto the catheter C, a sleeve or cover (not illustrated) may be used toconnect and secure together the protective tip T and the catheter C,thus preventing the protective tip T from detaching from the catheter C,and also to help protect the catheter C from touch contamination duringhandling and insertion.

FIGS. 2A and 3A illustrate another embodiment of a known protective tipT′. As in the embodiment of FIGS. 2 and 3, the protective tip or cap orcover T′ substantially encircles at least a portion of the proximal endP of a catheter C, but does not have a closed access end A. Instead, theprotective tip T′ of FIGS. 2A and 3A has a generally tubular bodyportion B′ defining an interior cavity V′ (FIG. 3A) that extends betweena distal open end O′ and a proximal open end G. The distal open end O′is the end of the protective tip T′ into which the catheter C isinserted (in a direction toward the proximal open end G). Unlike theaccess end A of FIGS. 2 and 3, the proximal open end G is not movableinto a closed condition, but remains open during use. Accordingly,rather than serving to isolate the proximal end P of the catheter C fromthe outside environment, the protective tip T′ serves as a gripper orgripping member that may be held by a user to manipulate and deploy thecatheter C without directly handling the catheter C, and so may bereferred to herein as a “gripper-type” protective tip. It should benoted that FIGS. 2 and 2A illustrate only two exemplary embodiments ofknown protective tips, and there are a number of other differentlyconfigured protective tips that are known and may be used in combinationwith the apparatus and methods described herein.

The present disclosure provides sleeveless urinary catheter assemblieswith a protective tip, thereby avoiding the cost associating withmanufacturing a sleeve and incorporating it into the catheter design.

SUMMARY

There are several aspects of the present subject matter which may beembodied separately or together in the devices and systems described andclaimed below. These aspects may be employed alone or in combinationwith other aspects of the subject matter described herein, and thedescription of these aspects together is not intended to preclude theuse of these aspects separately or the claiming of such aspectsseparately or in different combinations as set forth in the claimsappended hereto.

In one aspect, a protective tip is provided for use in combination witha urinary catheter of the type having at least one eye. The protectivetip includes a generally tubular body portion defining an interiorcavity. At least one projection extends into the interior cavity of thebody portion and is configured to be at least partially received by aneye of a urinary catheter at least partially positioned within the bodyportion.

In another aspect, a protective tip is provided for use in combinationwith a urinary catheter. The protective tip includes a generally tubularbody portion defining an interior cavity and at least one projectionextending into the interior cavity of the body portion. The projectionmay be configured to apply a generally uniform frictional force to anouter surface of a urinary catheter at least partially positioned withinthe body portion during use of the protective tip and the urinarycatheter.

In yet another aspect, a urinary catheter assembly includes a protectivetip, a urinary catheter, and a tether. The urinary catheter extendsbetween proximal and distal ends, with the proximal end being at leastpartially receivable within the protective tip. The tether extendsbetween the protective tip and the distal end of the urinary catheter.

In another aspect, a urinary catheter assembly includes a urinarycatheter and a protective tip received on the urinary catheter. Theprotective tip includes a proximal piece and a distal piece, with thedistal piece being separate from or detachably connected to the proximalpiece.

In yet another aspect, a protective tip is provided for use incombination with a urinary catheter having a proximal extension with anenlarged end and a necked-down section positioned adjacent to anddistally of the enlarged end. The protective tip includes an outermember and an insert at least partially received within the outermember. The insert includes a generally radially inwardly extendingprojection configured to be positioned distally of the enlarged end ofthe urinary catheter and to contact the enlarged end of the urinarycatheter to resist distal movement of the urinary catheter with respectto the protective tip.

In another aspect, a urinary catheter assembly includes a urinarycatheter having a proximal end portion with at least one eye. Aprotective sleeve tip defines an interior cavity receiving the proximalend portion of the urinary catheter. The protective sleeve tip is formedof a thin film material and includes at least one projection extendinginto the interior cavity and at least partially received by the at leastone eye of the urinary catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a male urinary catheter according to aknown design;

FIG. 2 is a side elevational view of a protective catheter tip accordingto a known design;

FIG. 2A is a side elevational view of another embodiment of a protectivecatheter tip according to a known design;

FIG. 3 is a cross-sectional view of a distal end of the catheter of FIG.1, received within the protective tip of FIG. 2;

FIG. 3A is a cross-sectional view of a distal end of the catheter ofFIG. 1, received within the protective tip of FIG. 2A;

FIG. 4 is a side elevational view of an embodiment of a sleevelessurinary catheter assembly having a protective tip, according to anaspect of the present disclosure;

FIG. 5 is a perspective view of an insert or adapter for associating aprotective tip to a urinary catheter;

FIG. 6 is an end view of the insert or adapter of FIG. 5 at leastpartially received within a protective tip of the type illustrated inFIG. 2;

FIG. 7 is a side elevational view of a protective tip of the typeillustrated in FIG. 2, with the insert or adapter of FIG. 5 at leastpartially received therein and shown in broken lines;

FIG. 8 is a perspective view of an alternative embodiment of the insertor adapter of FIG. 5;

FIG. 9 is a perspective view of another embodiment of a protectivecatheter tip according to a known design;

FIG. 10 is a perspective view of a protective tip of the typeillustrated in FIG. 9, with an insert or adapter according to an aspectof the present disclosure associated therewith;

FIG. 11 is a cross-sectional view of a sleeveless urinary catheterassembly having a protective tip tethered to a distal end of a urinarycatheter, according to an aspect of the present disclosure;

FIG. 12 is a perspective view of a protective catheter tip configuredfor use in a sleeveless urinary catheter assembly, according to anaspect of the present disclosure;

FIG. 12A is a perspective view of another embodiment of a protectivecatheter tip configured for use in a sleeveless urinary catheterassembly;

FIG. 13 is an end view of the protective tip of FIG. 12;

FIG. 14 is a cross-sectional view of the protective tip of FIG. 12,taken through the line 14-14 of FIG. 13 and showing a catheterpositioned within the protective tip;

FIG. 14A is a cross-sectional view of the protective tip of FIG. 12A,showing a catheter positioned within the protective tip;

FIG. 15 is a perspective view of an alternative embodiment of theprotective tip of FIG. 12;

FIG. 16 is a top plan view of the protective tip of FIG. 15;

FIGS. 17 and 18 are rear perspective views of the protective tip of FIG.15;

FIG. 19 is an end view of the protective tip of FIG. 15;

FIG. 20 is a cross-sectional view of the protective tip of FIG. 15,taken through the line 20-20 of FIG. 19;

FIGS. 21A-21D are perspective views of a two-piece protective tip andillustrate a method of separating the two pieces of the protective tip;

FIGS. 22A-22D are cross-sectional views of and further illustrate thetwo-piece protective tip and method of FIGS. 21A-21D;

FIGS. 23A-23C are perspective views of another embodiment of a two-pieceprotective tip, with the protective tip being configured for positioningat a distal end of the associated catheter prior to use;

FIGS. 24A-24C are perspective views of yet another embodiment of atwo-piece protective tip, with a distal piece of the protective tipbeing configured for positioning at a distal end of the associatedcatheter and a proximal piece positioned at a proximal end of thecatheter prior to use;

FIGS. 25A-25C are perspective views of another embodiment of a two-pieceprotective tip, with a distal piece of the protective tip beingconfigured for positioning at a midsection or intermediate portion ofthe associated catheter and a proximal piece positioned at a proximalend of the catheter prior to use;

FIGS. 26A and 26B are perspective views of yet another embodiment of atwo-piece protective tip, with a distal piece of the protective tipbeing a frangible partial sleeve;

FIG. 27 is a cross-sectional view of a protective tip provided incombination with a modified urinary catheter;

FIG. 28 is a cross-sectional, exploded view of the protective tip andurinary catheter of FIG. 27;

FIG. 29 is a cross-sectional, detail view of an insert of the protectivetip and a proximal end of the urinary catheter of FIG. 27;

FIG. 30 is a cross-sectional, detail view of the insert and urinarycatheter proximal end of FIG. 29, with the urinary catheter proximal endmoving in a distal direction with respect to the insert;

FIG. 31 is a cross-sectional, detail view of the insert and urinarycatheter proximal end of FIG. 29, with the urinary catheter proximal endmoving in a proximal direction with respect to the insert;

FIG. 32 is a side elevational view of a two-piece protective tip, withselected portions of the protective tip broken away for illustrativepurposes;

FIG. 33 is a side elevational view of another embodiment of a two-pieceprotective tip, with selected portions of the protective tip broken awayfor illustrative purposes;

FIG. 34 is a cross-sectional view of a two-piece protective tip for usein combination with an open-ended urinary catheter; and

FIG. 35 is a perspective view of a urinary catheter assembly having aurinary catheter enclosed within a protective sleeve tip.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing adescription of the present subject matter, and it is understood that thesubject matter may be embodied in various other forms and combinationsnot shown in detail. Therefore, specific embodiments and featuresdisclosed herein are not to be interpreted as limiting the subjectmatter as defined in the accompanying claims.

FIG. 4 shows a sleeveless urinary catheter assembly 10 according to thepresent disclosure. The sleeveless urinary catheter assembly 10 includesa urinary catheter 12, which extends between a proximal end 14 and adistal end 16. In the illustrated embodiment, the urinary catheter 12 isprovided according to conventional design (e.g., according to the designillustrated in FIG. 1 and discussed above), which may be advantageousfor retrofitting on-hand catheters into sleeveless assemblies. However,it is also within the scope for the urinary catheter 12 to have a noveldesign. Additionally, while it may be advantageous or preferred for theurinary catheter assemblies described herein to omit a protectivesleeve, it is also within the scope of the present disclosure for thefeatures and aspects described herein to be employed in combination withurinary catheter assemblies which include a protective sleeve.

The illustrated urinary catheter 12 is an elongated, hollow shaft ortube having a closed proximal insertion end portion 14 (as in FIG. 1)and an open distal end portion 16. The proximal end 14 includes ahemispherical or otherwise atraumatic tip that is suitable for insertioninto and passage through a body lumen or passageway of the body, such asthe urethra, for example. As described above, the proximal end 14 of thecatheter 12 includes draining holes or eyes (as in FIG. 1), while thedistal end 16 includes a connecting member, such as a funnel. Unlessstated to the contrary, the urinary catheters and sleeveless urinarycatheter assemblies described herein may be adapted for either male orfemale use.

The sleeveless urinary catheter assembly 10 of FIG. 4 further includes aprotective tip or cap or cover 20 that substantially encircles at leasta portion of the proximal end 14 of the catheter 12. As will bedescribed in greater detail, the protective tip 20 may be providedhaving an external appearance generally according to conventional design(e.g., according to the design illustrated in FIGS. 2 and 2A) or mayhave a novel design. For example, it may be preferred to employ amodified design that is longer than typical protective tips for improvedgripping, such as the protective tip of FIGS. 12 and 12A. In eithercase, the protective tip 20 may be retained upon the proximal end 14 ofthe catheter 12 without the presence of a sleeve or cover, which may beaccomplished in any of a variety of ways.

According to one method of securing the protective tip 20 to thecatheter 12, the sleeveless urinary catheter assembly includes an insertor adaptor that engages both a portion of the protective tip 20 and aportion of the catheter 12. FIG. 5 shows an exemplary embodiment of suchan insert 22, while FIGS. 6 and 7 show the insert 22 fully receivedwithin an interior cavity of the protective tip 20. In the illustratedembodiment, the insert 22 is generally annular, with an outer surface 24that engages or bears against an inner surface of the protective tip 20.The insert 22 may be provided so as to be held in place by a frictionfit or interference fit when positioned within the protective tip 20and/or it may be held in place by an adhesive or the like.

The inner surface 26 of the insert 22 includes an inwardly directedprojection 28. The projection 28 is configured to be at least partiallyreceived by an eye of a catheter 12 when the proximal end 14 of thecatheter 12 is positioned within the protective tip 20. FIG. 14 shows amodified protective tip (which will be discussed in greater detailherein) having projections extending into both eyes of the catheter, andit should be understood that the projection 28 of the insert 22 isreceived by one of the catheter eyes in the same manner. By extending atleast one projection into an eye of the catheter 12, the proximal end 14of the catheter 12 is held in place inside the protective tip 20 withoutthe need for a sleeve or cover to connect the protective tip 20 to thecatheter 12. Although the insert 22 is shown with a single projection28, it is within the scope of the present disclosure to provide morethan one projection. For example, the insert may include a secondprojection configured to be at least partially received by a second eyeof the catheter 12.

The illustrated projection 28 extends in a generally radial inwarddirection, with an inclined surface 30 and a radial surface 32. Whilethe inclined surface 30 and the radial surface 32 are illustrated asgenerally planar surfaces, they may be convex or curved or otherwisecontoured. When the insert 22 is received within the protective tip 20,the inclined surface 30 faces toward the open end of the protective tip20, while the radial surface 32 faces the access end of the protectivetip 20 (as in FIGS. 14 and 14A). To deploy the catheter 12 into aurethra, it is advanced proximally, in the direction of the access end.The inclined surface 30, if provided, allows the catheter 12 to moreeasily move in this direction, by deforming the catheter 12 and/or theprojection 28 as the catheter 12 presses against the inclined surface30, thereby allowing the projection 28 to disengage from the eye uponsufficient proximal movement of the catheter 12. In addition todisengaging the projection 28 from the eye upon relative proximalmovement of the catheter 12, it is also possible for the projection 28to be configured such that twisting or rotation of the catheter 12 aboutits central axis is also sufficient to disengage the projection 28 fromthe catheter eye.

In one embodiment, the projection 28 (or at least the portion of it thatis received by the catheter eye) may be relatively thin compared to thewidth of the eye to provide less resistance to proximal advancement ofthe catheter. For example, in the embodiment illustrated in FIG. 5, theprojection 28 includes a relatively wide base portion 34 and arelatively thin end portion 36. In such an embodiment, the base portiondoes not extend into the catheter eye, but instead provides additionalstrength to the projection 28 and may also help to orient the catheter12 with respect to the projection 28, as will be described in greaterdetail herein. The thinner end portion 36 may be adapted to provide thedesired amount of resistance to proximal or rotational movement of thecatheter 12 with respect to the projection 28.

As for the radial surface 32 of the projection 28, it serves to preventor at least hinder distal movement of the catheter 12 with respect tothe projection 28 (i.e., movement toward the open end of the protectivetip 20). More particularly, the radial surface 32 contacts the perimeterof the eye to effectively catch the eye and prevent the projection 28from being removed from the eye by distal movement of the catheter 12.In other embodiments, the projection may be differently configured, forexample, by having two inclined surfaces or two radial surfaces or twoor more non-inclined, non-radial surfaces.

In addition to the dimensions of the projection 28 and the extent towhich it extends into the catheter eye, the material composition of theprojection 28 may also affect the resistance to movement that itprovides. A relatively rigid material (or combination of materials) maybe used if additional resistance is desired, whereas a relativelyflexible material (or combination of materials) may be used if lessresistance is required. In one embodiment, it was found that aprojection 28 formed of silicone provided an advantageous combination ofrigidity and flexibility, but other materials may also be used withoutdeparting from the scope of the present disclosure.

The inner surface 26 of the insert 22 may further include an inwardlyextending guide or spacer 38. As shown in FIG. 3, there is typically agap between the inner surface of the protective tip and the outersurface of the catheter when the catheter is received within theprotective tip. If provided, a guide or spacer 38 inhabits the gapbetween the protective tip 20 and the catheter 12, thereby helping tomaintain the catheter 12 in a relatively coaxial relationship with theprotective tip 20. The extent to which the projection 28 extends intothe catheter eye has an effect upon the resistance that the catheter 12experiences when moving proximally or distally, so by controlling theposition of the catheter 12 with respect to the protective tip 20 (i.e.,by maintaining them in a generally coaxial relationship), theinteraction between the projection 28 and the eye can be bettercontrolled. As described above, the projection 28 itself may alsoinclude a portion (e.g., a base portion 34) that serves a similarpurpose to the guide 38, by occupying at least part of the space betweenthe inner surface of the protective tip 20 and the outer surface of thecatheter 12 to help orient the catheter 12 coaxially with respect to theprotective tip 20.

According to an alternative embodiment of the insert 22 of FIGS. 5-7,the insert may be provided with alternative means for securing it withrespect to the protective tip 20. For example, in the embodiment of FIG.8, an insert 40 is provided substantially according to the foregoingdescription of the insert 22 of FIGS. 5-7 with the exception that theinsert 40 includes a hook or clip 42 that may engage the open end of theprotective tip 20. In one embodiment, the clip 42 is generally C- orL-shaped (when viewed from the side), extending from the outer surfaceor one of the ends (e.g., the distal end) of the insert 40. The insert40 may be secured to the protective tip 20 by pressing it proximallyinto the interior cavity of the protective tip 20 via the open end. Aradially outward portion or leg 44 of the clip 42 remains outside of theinterior cavity and engages the outer surface of the protective tip 20to pinch or squeeze the protective tip 20 against the insert 40, therebyretaining the insert 40 in place. Other clip configurations or othermeans for securing an insert to a protective tip may also be employedwithout departing from the scope of the present disclosure.

According to another aspect of the present disclosure, a protective tipmay be secured to a catheter by a friction or interference fit, ratherthan by a projection extending into an eye of the catheter. For example,FIG. 9 shows the open distal end 46 of a protective tip 48. Theprotective tip 48 may be provided according to conventional design(e.g., according to the design illustrated in FIGS. 2 and 2A) or anyother suitable design. At the distal end 46 of the protective tip 48,the interior cavity of the protective tip 48 includes a generally radialwall 50 that defines a central opening or aperture 52 configured toreceive the proximal end of a catheter. The diameter of the centralopening 52 is selected to be sufficiently large so as to allow acatheter received therein to slide proximally and distally with respectto the protective tip 48.

In the illustrated embodiment, the central opening 52 is surrounded byan upstanding collar or rim 54 having a larger inner diameter than thecentral opening 52 and defining a distal portion of the interior cavityof the protective tip 48. According to an aspect of the presentdisclosure, an insert or adaptor 56 is received within the collar 54, asshown in FIG. 10. The insert 56 includes at least one projection 58 thatextends in a generally inward radial direction to bear against the outersurface of a catheter received within the protective tip 48. In theillustrated embodiment, the insert 56 includes three projections 58 thatare spaced equally along the inner perimeter of the generally annularinsert 56. In other embodiments, the insert may include fewer or morethan three projections 58, which may be spaced symmetrically orasymmetrically about the inner perimeter of the insert 56. Additionally,while FIG. 10 shows three substantially identical arcuate orsemicircular projections 58, it is also within the scope of the presentdisclosure for the projections to be differently configured.

The projections 58 provide a surface that bears against the outersurface of a catheter. The projections 58 combine to define a diameteror bearing surface that is smaller than the diameter of the centralopening 52 of the distal end 46 of the protective tip 48. The diameteror bearing surface defined by the projections 58 is preferablysufficiently small to provide a generally uniform frictional force tothe outer surface of the catheter, while still allowing the catheter tobe moved proximally and distally with respect to the protective tip 48.Upon application of sufficient force (which may be determined by anumber of factors including, but not limited to, the size of the bearingsurface defined by the projections 58, the number of projections 58, andthe material composition of the catheter and the insert 56), thecatheter may be moved proximally and distally with respect to theprotective tip 48. At applied forces that are less than the thresholdamount (e.g., during transportation of the sleeveless urinary catheterassembly, routine handling prior to use, and handling to align thecatheter with the urethra at the beginning of use), the bearing surfacedefined by the projections 58 provides a sufficiently great frictionalforce against the outer surface of the catheter so as to retain theprotective tip 48 in place. When a sufficient force has been applied tothe catheter and/or to the protective tip 48, the catheter movesproximally or distally with respect to the protective tip 48, but theprojections 58 remain stationary and apply the same frictional force tothe catheter.

The insert 56 may be secured to the protective tip 48 by means allowingit to be fully received within the interior cavity of the protective tip48, such as a friction fit or interference fit or adhesive or the like.The insert 56 may alternatively be secured to the protective tip 48 bymeans extending at least partially outside of the interior cavity, suchas a clip of the type shown in FIG. 8. Additionally, the insert 56 maybe associated with a different portion of the protective tip 48 and itis not limited to receipt within a collar 54 at the distal end 46 of theprotective tip 48.

In accordance with another aspect of the present disclosure, rather thanemploying an insert or adaptor, the protective tip 60 and catheter 62 ofa sleeveless urinary catheter assembly 64 are connected and securedtogether by a flexible element or filament or tether 66 (FIG. 11). Inthe embodiment of FIG. 11, an elongated tether 66 defines a loopattached to a portion of the protective tip 60 and the distal end 68(particularly, the funnel 70) of the catheter 62. The tether 66 may haveboth ends connected to the protective tip 60 or to the catheter 62, witha midsection of the tether 66 being secured to the other component ofthe sleeveless urinary catheter assembly 64 by suitable means (e.g.,adhesive or by receiving the tether 66 in a groove or channel or otherretaining formation). Alternatively, the tether 66 may define a closedloop, having its ends connected to each other to form a complete circle,in which case both the protective tip 60 and the catheter 62 may includea groove or channel or other retaining formation to receive the tether66 or an adhesive to secure the tether 66.

In another embodiment, rather than using a single tether, a plurality oftethers may be used to connect and secure together the protective tip 60and the catheter 62. If a plurality of tethers are provided, each tethermay define a loop (either a closed loop or one having both ends attachedto the protective tip 60 or the catheter 62) or instead have one endsecured to each of the protective tip 60 and the catheter 62. If morethan one tether is used, it may be advantageous for the tethers to besubstantially identical to each other or to at least have substantiallythe same length for a symmetrical interconnection between the protectivetip 60 and the catheter 62. However, it is within the scope of thepresent disclosure for a plurality of tethers to be differentlyconfigured.

Regardless of how many tethers are provided or how exactly they areconfigured, it is advantageous for them to be configured to preventremoval of the proximal end 72 of the catheter 62 from the open distalend 74 of the protective tip 60 without bending or otherwise deformingthe catheter 62. In other words, the length of the tether(s) should beselected such that proximal end 74 of the catheter 62 remains at leastpartially within the interior cavity 76 of the protective tip 60 evenupon distal movement of the catheter 62 with respect to the protectivetip 60 (i.e., movement in a left-to-right direction in the orientationof FIG. 11) to the point at which the tether 66 becomes taut andprevents further movement in that direction. To decrease the risk of thecatheter 62 being backed out of the protective tip 60, it may bepreferred to employ a relatively rigid catheter, rather than one that iseasily bendable or otherwise deformable. It may also be preferred to usesuch a catheter with the other sleeveless urinary catheter assembliesdescribed herein, although other catheters may also be used withoutdeparting from the scope of the present disclosure.

According to yet another aspect of the present disclosure, theprotective tip itself is adapted to be secured to the catheter in asleeveless urinary catheter assembly. For example, FIGS. 12-14 show oneembodiment of a protective tip 78 that is configured to maintain itselfon the proximal end of a urinary catheter. In particular, the protectivetip 78 includes at least one projection 80 extending into the interiorcavity 82 defined by the generally tubular body portion 84 of theprotective tip 78. The projection 80 may be configured according to thedescription of the projection 28 of FIG. 5, with an inclined surface 86and a radial surface 88 configured to be at least partially positionedwithin an eye 90 of a urinary catheter 92 at least partially positionedwithin the body portion 84 (FIG. 14). In the embodiment of FIGS. 12-14,there are two projections (a distal projection 80 and a proximalprojection 80 a) integrally formed with the body portion 84 andextending into the interior cavity 82 of the protective tip 78, witheach configured to be received by one of the eyes 90, 90 a of thecatheter 92. As in the insert of FIGS. 5-7, the interior cavity 82 ofthe protective tip 78 may be provided with one or more guide or spacerformations that help to properly orient the projection(s) 80, 80 a withrespect to the eye(s) 90, 90 a of the catheter 92.

FIGS. 12A and 14A illustrate an alternative embodiment of the protectivetip 78 of FIGS. 12-14, in which a “gripper-type” protective tip 78′ isprovided. As in the embodiment of FIGS. 12-14, the protective tip 78′ ofFIGS. 12A and 14A includes at least one projection 80′ extending intothe interior cavity 82′ defined by the generally tubular body portion84′ of the protective tip 78′. The projection 80′ may be configuredaccording to the description of the projection 28 of FIG. 5, with aninclined surface 86′ and a radial surface 88′ configured to be at leastpartially positioned within an eye 90 of a urinary catheter 92 which isat least partially positioned within the body portion 84′ (FIG. 14A). Inthe embodiment of FIGS. 12A and 14A, there are two projections (a distalprojection 80′ and a proximal projection 80′a) integrally formed withthe body portion 84′ and extending into the interior cavity 82′ of theprotective tip 78′, with each configured to be received by one of theeyes 90, 90 a of the catheter 92.

It is also within the scope of the present disclosure for the protectivetip to include only one projection. For example, FIGS. 15-20 show aprotective tip 94 having only one projection 96 that is integrallyformed with the body portion 98 of the protective tip 94 and configuredto be at least partially received by an eye of a urinary catheterpositioned within the protective tip 94. In the embodiment of FIGS.15-20, the body portion 98 of the protective tip 94 includes a slot 100aligned with and positioned proximally of the projection 96. Ifprovided, such a slot 100 may simplify the manufacture of the protectivetip 94 if it is formed in an injection molding procedure, as the slot100 represents the location of an insert or element positioned withinthe mold cavity to define the radial surface 102 of the projection 96.

It is also within the scope of the present disclosure for the protectivetip itself to have a multiple-piece construction, rather than beingprovided as a single, unitary piece. For example, FIGS. 21A-22D show anembodiment of a two-piece protective tip 104 according to an aspect ofthe present disclosure. The illustrated protective tip 104 includes aproximal piece or member 106 and a distal piece or member 108, with thetwo pieces 106 and 108 being detachably connected. As best seen in FIGS.22A-22D, the protective tip 104 includes at least one projection 110extending into the interior cavity 112 defined by the generally tubularbody portion of the protective tip 104. In the illustrated embodiment,two projections 110 and 110 a are provided and are configured accordingto the description of the projection 28 of FIG. 5, with an inclinedsurface and a radial surface configured to be at least partiallypositioned within an eye 114, 114 a of a urinary catheter 116 at leastpartially positioned within the body portion. In the illustratedembodiment, the projections 110 and 110 a extend from the proximal piece106, while there are no projections associated with the distal piece108, but it is also within the scope of the present disclosure for thedistal piece to also include one or more projections (e.g., comparableto the insert 56 and projections 58 of FIG. 10). It is also within thescope of the present disclosure for a two-piece protective tip to beprovided without projections and to be associated with a catheter by anyother suitable means.

It will be seen that the proximal piece 106 is comparable to the“introducer tip-type” protective tip 78 of FIGS. 12-14, while the distalpiece 108 is comparable to the “gripper-type” protective tip 78′ ofFIGS. 12A and 14A. More particularly, the illustrated proximal piece 106has a generally tubular body portion 118 that cooperates with the distalpiece 108 to define the interior cavity 112 that extends, in part,between an open distal end 120 and a proximal access end 122 of theproximal piece 106. As in other “introducer tip-type” protective tipsdescribed herein, the open end 120 is the end of the proximal piece 106into which the catheter 116 is inserted (in a direction toward theaccess end 122). The access end 122 is movable between a generallyclosed condition when the proximal end of the catheter 116 is positionedwithin the protective tip 104 and a generally open condition when thecatheter 116 is advanced proximally (i.e., in a left-to-right directionin the orientation of FIGS. 21A-21D or the upward direction in theorientation of FIGS. 22A-22D) so as to pass through the access end 122for advancement into and through the urethra. As shown, the access end122 of the proximal piece 106 may include one or more slits 124 thatallow it to move between the generally closed and generally openconditions.

As for the distal piece 108, it substantially encircles at least aportion of the proximal end of the catheter 116, but does not have aclosed access end. Instead, the distal piece 108 has a generally tubularbody portion 126 extending between open distal and proximal ends 128 and130 and combining with the proximal piece 106 to define the interiorcavity 112 of the protective tip 104. The distal open end 128 is the endof the distal piece 108 (and the protective tip 104) into which thecatheter 116 is inserted (in a direction toward the proximal piece 106).As in the “gripper-type” protective tips described above, the proximalopen end 130 is not movable into a closed condition, but remains openduring use, thereby allowing the distal piece 108 to serve as a gripperor gripping member that may be held by a user to manipulate and deploythe catheter 116 without directly handling the catheter 116. The distalpiece 108 may include one or more molded or formed portions, such as theillustrated oval-shaped formations (FIGS. 21A-21D), for improvedgripping and handling of the distal piece 108.

The distal end 120 of the proximal piece 106 and the proximal end 130 ofthe distal piece 108 include features or formations 132 and 134 (FIGS.22A-22D), respectively, configured to mate with each other to detachablysecure the pieces 106 and 108 of the protective tip 104 together. In theillustrated embodiment, the formation of the distal end 120 of theproximal piece 106 is an outwardly facing, generally annular rib 132.The rib 132 of the proximal piece 106 is configured to be receivedwithin an inwardly facing, generally annular channel or groove 134 thatcomprises the formation of the distal piece 108. One or both pieces 106,108 may be relatively rigid, but sufficiently flexible that, upon distalmovement of the distal piece 108 with respect to the proximal piece 106(FIGS. 21B, 21C, 22B, and 22D), one or both pieces 106, 108 deform toallow the rib 132 to unseat from the groove 134, thereby separating thetwo pieces 106 and 108. In one preferred embodiment, one or both of thepieces 106 and 108 (typically the distal piece 108) may be squeezed by auser to deform it, thereby unseating the rib 132 from the groove 134prior to moving the distal piece 108 distally to separate it from theproximal piece 106. It should be understood that the illustratedembodiment is merely exemplary and that other means for detachablyconnecting the proximal and distal pieces of a two-piece protective tip(e.g., mating screw threads or a separate connector) may also beemployed without departing from the scope of the present disclosure.

When the distal piece 108 has been fully separated from the proximalpiece 106, the distal piece 108 may be moved proximally and distally(FIGS. 21D and 22D), thereby permitting a user to manipulate thecatheter 116 without directly contacting (and potentially contaminating)it. If desirable, the two-piece protective tip 104 may be configured toallow for the two pieces 106 and 108 to be reconnected after beingdisconnected, as in the illustrated embodiment. In other embodiments,the connection between the two pieces may be frangible or otherwiseirreversible, thereby preventing reconnection of the two pieces afterthey have been disconnected.

FIGS. 23A-23C illustrate another embodiment of a two-piece protectivetip 200 according to an aspect of the present disclosure. Theillustrated protective tip 200 may be configured according to the abovedescription of the two-piece protective tip 104 of FIGS. 21A-22D, with aproximal piece 202 removably or detachably secured to a distal piece204. As in the embodiment of FIGS. 21A-22D, the proximal piece 202 maybe comparable to the “introducer tip-type” protective tip 78 of FIGS.12-14, while the distal piece 204 is comparable to the “gripper-type”protective tip 78′ of FIGS. 12A and 14A. The two pieces 202 and 204 maybe detachably connected together at the distal end of the proximal piece202 and the proximal end of the distal piece 204 according to therib-and-groove arrangement described above with respect to theprotective tip 104 of FIGS. 21A-22D or by any other suitable detachableconnection arrangement.

In one embodiment, the protective tip 200 differs from the protectivetip 104 of FIGS. 21A-22D by omitting an internal projection for receiptwithin an eye 206 of the associated catheter 208, but instead reliesupon an access end 210 (of the type described above in greater detail)of the proximal piece 202 to engage the outer surface of the catheter208 and hold the protective tip 200 in place on the catheter 208, whilealso allowing the protective tip 200 to be moved along the length of thecatheter 208. However, it is also within the scope of the presentdisclosure for the tip 200 to be provided with one or more internalprojections of the type described above or to be associated with thecatheter 208 by any other suitable means.

Also in contrast to the embodiment of FIGS. 21A-22D, the protective tip200 of FIGS. 23A-23C is not positioned at the proximal end of thecatheter 208 prior to use, but is instead positioned at a distal end ofthe catheter 208, associated with a connecting member or funnel 212 atthe distal end prior to use (e.g., while the protective tip 200 andcatheter 208 are in a sterile package or container or wrapper), as shownin FIG. 23A. The funnel 212 may be provided according to conventionaldesign for fluidly connecting the catheter 208 to a collectioncontainer, such as a collection bag into which urine drains. Preferably,the funnel 212 and/or an interior portion of the distal piece 204include molded or formed contours or features that allow for the funnel212 to detachably engage the distal piece 204 and the protective tip 200prior to use. For example, the funnel 212 and the distal piece 204 maybe configured such that there is a friction or interference fittherebetween that holds the protective tip 200 in place on the funnel212 prior to use. In other embodiments, the protective tip 200 may beassociated to the funnel 212 by a frangible connection or by a separateconnector or fastener.

When a user is ready to use the catheter 208, it is removed from thepackaging and the protective tip 200 is detached from the funnel 212.The manner in which the protective tip 200 is removed from the funnel212 may vary depending on the mechanism by which the two are connected.In various exemplary embodiments, the protective tip 200 may be detachedfrom the funnel 212 by rotating the protective tip 200 with respect tothe funnel and/or by holding the funnel 212 in one hand and theprotective tip 200 in the other while moving the protective tip 200 in aproximal relative direction with respect to the funnel 212.

With the protective tip 200 fully detached from the funnel 212, theprotective tip 200 may be slid along the catheter 208 in a proximaldirection, as shown in FIG. 23B. The protective tip 200 is advancedproximally along the catheter 208 until the access end 210 at theproximal end of the protective tip 200 clears the proximal end of thecatheter 208 and moves from an open condition (with the catheter 208extending therethrough, as in FIGS. 23A and 23B) to a closed condition,as shown in FIG. 23C. When the protective tip 200 is in this position,the distal piece 204 may be detached from the proximal piece 202according to the method described above in greater detail with respectto the embodiment of FIGS. 21A-22D or according to any other suitablemeans.

Finally, when the two pieces 202 and 204 of the protective tip 200 areseparated from each other, the distal piece 204 may be moved proximallyand distally (FIG. 23C), thereby permitting a user to manipulate thecatheter 208 without directly contacting (and potentially contaminating)it. The two-piece protective tip 200 may be configured to allow for thetwo pieces 202 and 204 to be reconnected after being disconnected, suchas by pressing them distally until the distal piece 204 engages thefunnel 212 and the distal end of the proximal piece 202 reconnects tothe proximal end of the distal piece 204 (i.e., by returning thecatheter 208 and protective tip 200 to the initial condition of FIG.23A). In other embodiments, the connection between the two pieces may befrangible or otherwise irreversible, thereby preventing reconnection ofthe two pieces after they have been disconnected.

FIGS. 24A-24C illustrate another embodiment of a two-piece protectivetip according to an aspect of the present disclosure. The illustratedprotective tip may be configured generally according to the abovedescription of the two-piece protective tip 104 of FIGS. 21A-22D, with aproximal piece 300 that is comparable to the “introducer tip-type”protective tip 78 of FIGS. 12-14, while the distal piece 302 iscomparable to the “gripper-type” protective tip 78′ of FIGS. 12A and14A. In the illustrated embodiment, the proximal piece 300 includes atleast one internal projection 304 received by an eye 306 of the catheter308 (as described above in greater detail with respect to the embodimentof FIGS. 12-14), while the distal piece 302 omits such an internalprojection. In other embodiments, the proximal piece 300 may include anyother suitable means for movably securing it in place at a proximal endof the catheter 308.

In contrast to the embodiment of FIGS. 23A-23C, only the distal piece302 of the protective tip is initially positioned at the distal end ofthe catheter 308 and detachably connected to a funnel 310 at the distalend prior to use, as shown in FIGS. 24A and 24B. While the distal piece302 is initially connected to the funnel 310, the proximal piece 300 isinitially detachably connected to the proximal end of the catheter 308(as in the embodiment of FIGS. 12-14) while the protective tip andcatheter 308 are in a sterile package or container or wrapper. Asdescribed above with respect to the embodiment of FIGS. 23A-23C, thefunnel 310 and/or an interior portion of the distal piece 302 preferablyinclude molded or formed contours or features that allow for the funnel310 to detachably engage the distal piece 302 prior to use.

When a user is ready to use the catheter 308, it is removed from thepackaging and the distal piece 302 of the protective tip is detachedfrom the funnel 310. The manner in which the distal piece 302 is removedfrom the funnel 310 may vary depending on the mechanism by which the twoare connected. In various exemplary embodiments, the distal piece 302may be detached from the funnel 310 by rotating the distal piece 302with respect to the funnel and/or by holding the funnel 310 in one handand the distal piece 302 in the other while moving the distal piece 302in a proximal relative direction with respect to the funnel 310.

With the distal piece 302 of the protective tip fully detached from thefunnel 310, the distal piece 302 may be moved proximally and distally(FIG. 24C), thereby permitting a user to manipulate the catheter 308without directly contacting (and potentially contaminating) it. Afteruse, the distal piece 302 may be moved distally along the catheter 308to reengage the funnel 310 for disposal of the catheter 308. In otherembodiments, the connection between the distal piece 302 and the funnel310 may be frangible or otherwise irreversible, thereby preventingreconnection of the distal piece 302 and the funnel 310 after they havebeen disconnected.

FIGS. 25A-25C illustrate another embodiment of a two-piece protectivetip according to an aspect of the present disclosure. The illustratedprotective tip may be configured generally according to the abovedescription of the two-piece protective tip of FIGS. 24A-24C, with aproximal piece 400 that is comparable to the “introducer tip-type”protective tip 78 of FIGS. 12-14 and a distal piece 402 that iscomparable to the “gripper-type” protective tip 78′ of FIGS. 12A and14A. In the illustrated embodiment, the proximal piece 400 includes atleast one internal projection 404 received by an eye 406 of the catheter408, while the distal piece 302 omits such an internal projection. Inother embodiments, the proximal piece 400 may include any other suitablemeans for movably securing it in place at a proximal end of the catheter408.

As in the embodiment of FIGS. 24A-24C, the proximal piece 400 of theprotective tip is initially detachably connected to the proximal end ofthe catheter 408 prior to use (e.g., while the protective tip andcatheter 408 are in a sterile package or container or wrapper). However,in contrast to the embodiment of FIGS. 24A-24C, the distal piece 402 isinitially positioned at a midsection or intermediate portion of thecatheter 408, between the proximal piece 400 and the funnel 410 at thedistal end of the catheter 408, rather than being detachably connectedto the funnel 410. The distal piece 402 may be fully separate from thecatheter 408 or have an internal projection or formation configured toengage the outer surface of the catheter 408, such as a projection ofthe type described above in greater detail with respect to theembodiment of FIG. 10.

When a user is ready to use the catheter 408, it is removed from thepackaging and the distal piece 402 may be moved proximally (FIG. 25B)and distally (FIG. 25C), thereby permitting a user to manipulate thecatheter 408 without directly contacting (and potentially contaminating)it.

FIGS. 26A and 26B show yet another embodiment of a two-piece protectivetip 500 according to an aspect of the present disclosure. Theillustrated protective tip 500 includes a proximal piece or member 502and a distal piece or member 504. The proximal piece 502 may becomparable to the “introducer tip-type” protective tip 78 of FIGS.12-14, with one or more internal projections that are received withineyes at the proximal end of the catheter 506 to detachably secure theproximal piece 502 to the proximal end of the catheter 506. It is alsowithin the scope of the present disclosure for the proximal piece 502 ofthe protective tip 500 to be detachably secured to the proximal end ofthe catheter 506 by any other suitable means.

As for the distal piece 504, it comprises a relatively short sleeve witha fixed portion 508 and a free portion 510. In one embodiment, thedistal piece 504 is formed from one or more thin, flexible sheets ofmaterial, such as a polymeric material (e.g., polyethylene) or the like.The fixed portion 508 is secured to the proximal piece 502 by anysuitable means, which may vary depending on the configuration andmaterial composition of the proximal and distal pieces 502 and 504. Inone embodiment, the fixed portion 508 is secured to the proximal piece502 by a heat seal, but other means (e.g., adhesive or mechanicalfasteners) may also be employed without departing from the scope of thepresent disclosure. The free portion 510 encircles a portion of thecatheter 506 without being secured thereto.

The distal piece 504 is relatively short compared to the length of thecatheter 506, such that the distal piece 504 extends only partiallyalong the length of the catheter 506. Preferably, the free portion 510is sufficiently elongated that it may be gripped by a user formanipulating the catheter 506, without being overly elongated. Forexample, the distal piece 504 may be configured such that its overalllength is approximately four inches, with the free portion 510 beingbetween two and three inches long. In other embodiments, the length ofthe distal piece 504 and the free portion 510 may vary without departingfrom the scope of the present disclosure.

The fixed and free portions 508 and 510 of the distal piece 504 have afrangible portion 512 therebetween that may be torn or broken or severedto separate the fixed and free portions 508 and 510. The frangibleportion 512 may be variously configured without departing from the scopeof the present disclosure, but in the illustrated embodiment, thefrangible portion 512 may comprise a line of perforations that may betorn or broken or severed to separate the fixed and free portions 508and 510 of the distal piece 504.

In use, the proximal piece 502 and/or the fixed portion 508 of thedistal piece 504 are gripped with one hand, while the free portion 510of the distal piece 504 is gripped with the other hand. The user thenmoves the free portion 510 in a distal direction relative to theproximal piece 502 until the frangible portion 512 tears or breaks toseparate the free portion 510 of the distal piece 504 from the fixedportion 508. When the free portion 510 has been fully separated from theproximal piece 502 (and from the fixed portion 508 of the distal piece504), the free portion 510 may be moved proximally and distally (FIG.26B), thereby permitting a user to manipulate the catheter 506 withoutdirectly contacting (and potentially contaminating) it.

FIGS. 27-31 illustrate another embodiment of a sleeveless urinarycatheter assembly 600 according to the present disclosure. In contrastto the other embodiments described herein, the sleeveless urinarycatheter assembly 600 incorporates a modified catheter 602. Theillustrated catheter 602 comprises a catheter body 604 that may beprovided generally according to the convention design (e.g., extendingbetween proximal and distal end sections, with one or more eyes 606 ator adjacent to the proximal end section 608 and a funnel or the like atthe distal end section). Associated with the proximal end section 608 ofthe catheter body 604 is an extension 610 comprising a necked-downsection 612 and a proximal or enlarged end 614. Although the proximalend 614 of the extension 610 may be referred to as an “enlarged” end, itis preferably enlarged only with respect to the necked-down section 612(as will be described in greater detail below) and has a maximum outerdiameter that is no greater than the maximum outer diameter of thecatheter body 604. Furthermore, it may also be preferred for theextension 610 to be generally coaxial with the catheter body 604, asthese two design features may provide improved comfort of a user of thesleeveless urinary catheter assembly 600.

Depending on the nature of the catheter body 604 and the extension 610(e.g., their material compositions and shapes), the manner by which theextension 610 is secured to the catheter body 604 may vary withoutdeparting from the scope of the present disclosure. In one embodiment,the extension 610 and the catheter body 604 are manufactured fromsimilar materials (e.g., polymer materials), with the extension 610being more flexible than the catheter body 604 (e.g., by beingmanufactured from a material having a lower durometer hardness, and/or alower modulus of elasticity). The material composition of the extension610 may vary without departing from the scope of the present disclosure,but it may be preferred for the extension 610 to be manufactured so asto feel and perform similarly to a conventional catheter during use. Itshould also be understood that the catheter body 604 and the extension610 are not necessarily provided separately, but the extension 610 maybe integrally formed as a proximal end of the catheter body 604 havingan enlarged section.

The illustrated necked-down portion 612 is shown as having a generallycylindrical or frusto-conical shape, while the proximal end 614 has agenerally spherical or bulb shape, with a proximal region of thenecked-down portion 612 tapering outwardly to smoothly transition to adistal region of the proximal end 614. However, other configurations maybe employed without departing from the scope of the present disclosure.As noted above, it is preferred for at least a portion of thenecked-down section 612 to have a diameter that is less than the maximumdiameter of the proximal end 614 of the extension 610 (as in theillustrated embodiment) in order to retain at least a portion of theextension 610 within a protective tip 616, as will be described ingreater detail below.

Turning now to the protective tip 616 of the sleeveless urinary catheterassembly 600, it includes an outer member or piece 618 and an innermember or piece or insert 620. In the illustrated embodiment, the outermember 618 is configured similarly to an “introducer tip-type”protective tip of the type shown in FIGS. 2 and 3. In other embodiments,the outer member 618 may be provided as a “gripper-type” protective tipof the type shown in FIGS. 2A and 3A or in any other suitableconfiguration.

The insert 620 is configured to be at least partially received within aninterior cavity 622 defined by a generally tubular body portion 624 ofthe outer member 618 that extends between proximal and distal endsections of the outer member 618. The distal open end 626 is the end ofthe outer member 618 into which the insert 620 is inserted, in adirection toward the proximal end, as shown in FIG. 28. In theillustrated embodiment, the insert 620 is secured to the distal end 626of the outer member 618, with a small portion of the insert 620extending outside of the cavity 622 to properly orient the insert 620and prevent over-insertion thereof into the outer member 618. However,in other embodiments, the insert 620 may be secured to any otherinterior region of the body portion 624 of the outer member 618 to beeither fully or partially received within the cavity 622. In oneembodiment, the insert 620 may be secured within the outer member 618 bya friction fit or interference fit when positioned within the outermember 618 and/or it may be held in place by an adhesive or the like. Inother embodiments, other means may be provided for associating theinsert 620 to the outer member 618.

The exact structure of an exemplary insert 620 is shown in greaterdetail in FIGS. 29-31. In the illustrated embodiment, the insert 620includes a body portion 628 configured to be secured to the outer member618. The configuration of the body portion 628 is preferablycomplementary to the shape of the portion of the outer member 618 towhich it is to be secured. For example, in the illustrated embodiment,the body portion 628 of the insert 620 is generally tubular to match theshape of the generally tubular body portion 624 of the outer member 618to which it is secured. However, the shape of the body portion 628 mayvary without departing from the scope of the present disclosure.

Associated with the body portion 628 of the insert 620 is a projection630. The projection 630 extends generally radially inwardly and may bevariously configured. For example, the projection 630 may be generallyannular or comprise a plurality of inwardly extending “fingers” orsegments. Regardless of the exact shape of the projection 630, itdefines an opening or aperture 632 through which the necked-down section612 of the extension 610 extends, as shown in FIGS. 29-31. The diameterof the opening 632 is smaller than a maximum diameter of the proximalend 614 of the catheter extension 610, but may be comparable to thediameter of the necked-down section 612, as in FIG. 29, or it may belarger or smaller than the diameter of the necked-down section 612. In apreferred embodiment, the projection 630 is hingedly or pivotallyconnected to the body portion 628 of the insert 620, such that theorientation of the projection 630 may vary to effectively change thediameter of the opening 632. In the illustrated embodiment, the insert620 includes an integrally formed hinge 634 positioned adjacent to theprojection 630. The illustrated hinge 634 is a relatively narrowproximal end section of the body portion 628, which provides increasedflexibility on account of being relatively narrow. While the illustratedinsert 620 includes an integrally formed projection 630 and hinge 634,it is within the scope of the present disclosure for either or both ofthese components to be separately provided.

By providing a hinge 634 or comparable structure, the projection 630 maypivot or rotate with respect to the remainder of the insert 620. Forexample, FIG. 29 shows the projection 630 in a neutral or un-pivotedorientation. FIG. 30 shows the projection 630 pivoting or rotating inone direction, while FIG. 31 shows the projection 630 pivoting orrotating in an opposite direction. When the projection 630 pivots towardthe hinge 634 (as in FIG. 30), the projection 630 may come into contactwith the hinge 634 or some other part of the insert 620 to limit itspivotal movement in that direction. When the projection 630 pivots awayfrom the hinge 634 (as in FIG. 31), the projection 630 may come intocontact with a portion of the outer member 618 to limit its pivotalmovement in that direction. The material composition of the projection630 may also or alternatively limit the pivotal movement of theprojection 630 in either direction.

FIG. 28 shows the catheter 602 initially separate from the protectivetip 616 prior to assembly. The catheter 602 is associated to theprotective tip 616 by relative movement of the catheter 602 towardinsert 620 (i.e., in a right-to-left direction in the orientation ofFIG. 28), with the extension 610 facing the insert 620. Alternatively,the catheter body 604 may be pulled through the insert 620 (in aleft-to-right direction in the orientation of FIG. 28) to arrive at theconfiguration of FIGS. 27 and 29, in which the necked-down portion 612of the catheter extension 610 is received by the opening 632 of theinsert 620, with the proximal end 614 and catheter body 604 on oppositesides of the projection 630. The catheter 602 may be so associated tothe insert 620 prior to or after the insert 620 has been associated tothe outer member 618 or at substantially the same time.

With the sleeveless urinary catheter assembly 600 in the configurationof FIG. 27, it is ready for handling and use. Prior to introduction ofthe catheter 602 into the urethra, the insert 620 prevents the catheter602 from being retracted or withdrawn from the protective tip 616. Moreparticularly, FIG. 30 shows the catheter extension 610 being moved in adistal direction wherein the proximal end 614 of the catheter extension610 comes into contact with the projection 630 of the insert 620, onaccount of the proximal end 614 having a larger diameter than theopening 632 of the insert 620. Continued distal movement of the catheterextension 610 may pivot the projection 630 about the hinge 634 to somedegree, but the projection 630 is eventually prevented from furtherrotational or pivotal movement (as described above). When the pivotalmovement of the projection 630 has ceased, further distal movement ofthe catheter extension 610 is prevented by interference between theprojection 630 and the proximal end 614 of the catheter extension 610,thereby retaining the catheter extension 610 within the protective tip616 and maintaining sterility prior to use. While FIG. 30 shows only thecatheter extension 610 positioned and retained within the protective tip616, it is within the scope of the present disclosure for some portionof the catheter body 604 to also be positioned and retained within theprotective tip 616 prior to use.

When the catheter 602 is to be inserted into the urethra, it is movedproximally with respect to the protective tip 616 (i.e., in theright-to-left direction in the orientation of FIG. 27). FIG. 31 showshow the projection 630 of the insert 620 allows unrestricted proximalrelative movement of the catheter extension 610, on account of thenecked-down section 612 of the catheter extension 610 (as well as thecatheter body 604) having a smaller diameter than the opening 632defined by the projection 630 when the projection 630 pivots away fromthe hinge 634. When it is desired to withdraw the catheter 602 from theurethra, it may be moved distally with respect to the protective tip 616until the proximal end 614 of the catheter extension 610 engages and isretained by the projection 630, as shown in FIG. 30.

FIG. 32 illustrates another embodiment of a protective tip 700 accordingto an aspect of the present disclosure. The illustrated protective tip700 is provided as a single component, but includes distal and proximalportions or pieces 702 and 704 formed of different materials, which aresecured together. The protective tip 700 includes at least oneprojection 706 extending into the interior cavity defined by thegenerally tubular body portion of the protective tip 700. In theillustrated embodiment, one projection 706 is provided and may beconfigured according to the description of the projection 28 of FIG. 5,with an inclined surface and a radial surface configured to be at leastpartially positioned within an eye 708 of a urinary catheter 710 atleast partially positioned within the body portion. In the illustratedembodiment, the projection 706 extends from the distal piece 702, whilethere are no projections associated with the proximal piece 704, but itis also within the scope of the present disclosure for the proximalpiece 704 to also include one or more projections (as shown in theembodiment of FIG. 33, as will be described in greater detail herein).

The distal piece 702 may be similarly configured to the distal sectionof the protective tip 94 of FIGS. 15-20, with a tubular body or barrel712 associated with the distal face of a generally annular flange 714having a larger outer diameter than the tubular barrel 712. The distalpiece 702 may be a molded component, which is formed of a generallyrigid material, a generally flexible or resilient material, or amaterial having intermediate rigidity. It may be preferred for thedistal piece 702 to have a greater rigidity or stiffness than theproximal piece 704.

As for the proximal piece 704, it is shaped similarly to the proximalsection of the protective tip 94 of FIGS. 15-20, extending from aproximal face of the flange 714 and having an outer diameter sized tofit within a urethra. The proximal end 716 of the proximal piece 704 isprovided in an initially closed condition to enclose the proximal endportion 718 of an associated urinary catheter 710. The proximal piece704 of the protective tip 700 is preferably formed of a relatively thinmaterial having a high moisture vapor transmission rate (e.g.,polyurethane) to ensure that the proximal end portion 718 of the urinarycatheter 710 is adequately hydrated. Preferably, the material of theproximal piece 704 is inherently lubricious, but it is also within thescope of the present disclosure for the material of the proximal piece704 to be non-lubricious, in which case a lubricant may be applied tothe proximal piece 704 prior to advancement into a urethra. Typically, aproximal piece 704 formed of a thin film will have a smaller outerdiameter than the proximal sections of the protective tips describedabove, in which case the protective tip 704 may be less intimidating toa user. While only the embodiments of FIGS. 32 and 33 are illustrated ashaving thin film proximal sections, it should be understood that theother protective tips described herein may be provided with proximalsections formed of a thin film material. Protective tips having aproximal end or piece formed of a thin film material (which may bereferred to as “protective sleeve tips”) are described in greater detailin PCT Patent Application Publication No. WO 2013/130459 A1, which isincorporated herein by reference.

In a protective tip 700 having a proximal piece 704 formed of a thinfilm, the proximal end 716 of the proximal piece 704 is configured tomove only from the closed condition of FIG. 32 to an open condition, incontrast to the other protective tips described herein, which haveproximal ends that are configured to move between open and closedconditions. The proximal end 716 of the proximal piece 704 may include aweakened section 720 that is rupturable or frangible or capable of beingmanipulated to move it from the closed condition to the open condition.For example, the proximal end 720 may include a sealed opening or slitor aperture or one or more perforations that is configured to yield to aurinary catheter 710 moved proximally within the interior cavity of theprotective tip 700. Upon sufficient relative proximal movement, theproximal end portion 718 of the urinary catheter 710 presses against theproximal end 716 of the proximal piece 704 and unseals or ruptures orbreaks or otherwise irreversibly moves the weakened section 720 from theclosed condition to an open condition. Typically, this occurs after theproximal piece 704 has been advanced into a urethra until the flange 714prevents further proximal advancement. The urinary catheter 710 is thenmoved proximally with respect to the protective tip 700 (which requiresmoving the projection 706 out of the catheter eye 708) to pass throughthe weakened section 720 of the proximal end 716 (by moving the weakenedsection 720 to the open condition), thereby passing into the urethrawithout being exposed to the outside environment.

The proximal piece 704 may be secured to the distal piece 702 at any ofa number of suitable locations, such as to the proximal face of theflange 714 or to the inner surface of the barrel 712 of the distal piece702. In another embodiment, the proximal piece 704 may be secured to thedistal end of the distal piece 702 and extend proximally through theinterior of the distal piece 702. The distal and proximal pieces 702 and704 may be secured together by any suitable means, which may varydepending on the material compositions of the distal and proximal pieces702 and 704.

As mentioned above, FIG. 33 illustrates a variation of the protectivetip 700 of FIG. 32. The protective tip 700′ of FIG. 33 includes a distalportion or piece 702′ secured to a proximal portion or piece 704′, as inthe embodiment of FIG. 32. In contrast to the embodiment of FIG. 32, thedistal piece 702′ of the protective tip 700′ of FIG. 33 omits aprojection, and may instead have a generally smooth or featureless innersurface. The projection 706′ is instead associated with the proximalpiece 704′, extending into the interior cavity of the protective tip700′, where it is at least partially received within an eye 708′ of anassociated urinary catheter 710′. In the embodiment of FIG. 33, only oneprojection 706′ is provided to be at least partially received within thedistal catheter eye 708′, but it is also within the scope of the presentdisclosure for a projection to instead be at least partially receivedwithin the proximal catheter eye 722. Additionally, the proximal piece704′ may include a pair of projections, with one projection beingreceived in each catheter eye 708′, 722, or the distal and proximalpieces 702′ and 704′ may each include one projection that is received inone of the catheter eyes 708′, 722.

The projection 706′ may be formed by pressing or otherwise advancing thefilm material overlaying the eye 708′ inwardly into the hollow interiorof the urinary catheter 710′ through the eye 708′. The film material maythen be secured to the inner surface 724 of the urinary catheter 710′ todefine the projection 706′. It may be advantageous for the film materialof the proximal piece 704′ to be weakly secured to the inner surface 724of the urinary catheter 710′, such that the film material is presentwithin the eye 708′ to provide a retention feature, withoutsignificantly resisting detachment from the urinary catheter 710′ as theurinary catheter 710′ is moved proximally with respect to the protectivetip 700′. In one embodiment, the film material of the proximal piece704′ is secured to the inner surface 724 of the urinary catheter 710′ bya peelable heat seal or tack weld or thermal bond. Preferably, theprojection 706′ is configured such that the seal between the projection706′ and the urinary catheter 710′ will separate upon application of thestandard force that a user would apply when advancing the urinarycatheter 710′ into the urethra. One method of creating such a sealinvolves the use of materials that have poor melt temperaturecompatibility and demonstrate poor adhesion once wet and sterilized,such as a DUREFLEX® U073 polyurethane film material from BayerMaterialScience LLC of South Deerfield, Mass., and a polyvinyl chlorideurinary catheter material.

FIG. 34 illustrates a sleeveless urinary catheter assembly that is avariation of the assembly shown in FIG. 33. The protective tip 700″ ofFIG. 34 includes a distal portion or piece 702″ secured to a proximalportion or piece 704″, as in the embodiment of FIG. 33. In contrast tothe embodiment of FIG. 33, the associated urinary catheter 710″ isopen-ended, with an eye 708″ positioned at the proximal end 726 of theurinary catheter 710″, rather than being defined in a lateral wall ofthe proximal end portion 718″. As in the embodiment of FIG. 33, theproximal piece 704″ includes a projection 706″ that extends into theinterior cavity of the protective tip 700″, where it is at leastpartially received within the eye 708″ of the associated urinarycatheter 710″.

The projection 706″ may be formed by pressing or otherwise advancing thefilm material at the proximal end of the proximal piece 704″ distallyinto the hollow interior of the urinary catheter 710″ through the eye708″. The film material may then be secured to the inner surface 724″ ofthe urinary catheter 710″ to define the projection 706″. As in theembodiment of FIG. 33, it may be advantageous for the film material ofthe proximal piece 704″ to be weakly secured to the inner surface 724″of the urinary catheter 710″, such that the film material is presentwithin the eye 708″ to provide a retention feature, withoutsignificantly resisting detachment from the urinary catheter 710″ as theurinary catheter 710″ is moved proximally with respect to the protectivetip 700″. For example, the film material of the proximal piece 704″ maybe secured to the inner surface 724″ of the urinary catheter 710″ by apeelable heat seal or tack weld or thermal bond. Preferably, theprojection 706″ is configured such that the seal between the projection706″ and the urinary catheter 710″ will separate upon application of thestandard force that a user would apply when advancing the urinarycatheter 710″ into the urethra. As described above with respect to theembodiment of FIG. 33, one method of creating such a seal involves theuse of materials that have poor melt temperature compatibility anddemonstrate poor adhesion once wet and sterilized, such as a DUREFLEX®U073 polyurethane film material from Bayer MaterialScience LLC of SouthDeerfield, Mass., and a polyvinyl chloride urinary catheter material.

In the illustrated embodiment, an annular seal 728 is formed between thebetween the proximal piece 704″ and the inner surface 724″ of theurinary catheter 710″ to form the projection 706″. If the proximal piece704″ is formed of a tubular or open-ended material, then the eye 708″ ofthe urinary catheter 710″ will remain open (as shown in FIG. 34),whereas a projection formed by an annular seal will block and overlaythe eye 708″ if the proximal piece has a closed end. If the proximalpiece has a closed end, it preferably includes a weakened section, as inthe embodiments of FIGS. 32 and 33, to ensure that the urinary catheter710″ may be advanced proximally through the proximal piece during use.While FIG. 34 shows the projection 706″ secured to the urinary catheter710″ by an annular seal 728, it is within the scope of the presentdisclosure for the projection 706″ to be secured to the urinary catheter710″ by a non-annular seal, such as by sealing the film material to theurinary catheter 710″ at only one or more locations along an innerperimeter of the urinary catheter 710″, rather than sealing the filmmaterial along an entire inner perimeter.

FIG. 35 illustrates a urinary catheter assembly 800 that may beunderstood as a variation of the one shown in FIG. 33. As describedabove in greater detail, the protective tip 700′ of FIG. 33 has atwo-piece construction, with a proximal protective sleeve tip 704′formed of a film material secured to a molded distal piece 702′.Compared to the protective tip 700′ of FIG. 33, the embodiment of FIG.35 eliminates the distal piece and extends and elongates the protectivesleeve tip 802 to the extent that it covers and encloses the entireassociated urinary catheter 804. More particularly, the illustratedprotective tip or protective sleeve tip 802 extends between a closedproximal end 806 and an open distal end 808. As in the embodiments ofFIGS. 32 and 33, the proximal end 806 of the protective sleeve tip 802preferably includes a weakened section that is rupturable or frangibleor capable of being manipulated to move it from the closed condition toan open condition, in which at least the proximal end portion 810 of theurinary catheter 804 may be proximally advanced. For example, theproximal end 806 of the protective sleeve tip 802 may include a sealedopening or slit or aperture or one or more perforations that isconfigured to yield when the urinary catheter 804 is moved proximallywithin the interior cavity of the protective sleeve tip 802. Uponsufficient relative proximal movement, the proximal end portion 810 ofthe urinary catheter 802 presses against the proximal end 806 of theprotective sleeve tip 802 and unseals or ruptures or breaks or otherwiseirreversibly moves the weakened section from the closed condition to anopen condition.

The proximal end 806 of the protective sleeve tip 802 or a portionadjacent thereto may be formed with a projection 812 that extends intothe interior cavity defined by the generally tubular body portion of theprotective sleeve tip 802 to be at least partially received by an eye814 of the urinary catheter 802. The projection 812 of the protectivesleeve tip 802 of FIG. 35 may be formed and configured according to theabove description of the projection 706′ of FIG. 33, for example bypressing or otherwise advancing the film material overlaying the eye 814inwardly into the hollow interior of the urinary catheter 804 throughthe eye 814 and then securing the film material to an inner surface ofthe urinary catheter 804 to define the projection 812. As in theembodiment of FIG. 33, it may be advantageous for the projection 812 tobe weakly secured to the inner surface of the urinary catheter 804(e.g., by a peelable heat seal or tack weld or thermal bond), such thatthe film material is present within the eye 814 to provide a retentionfeature, without significantly resisting detachment from the urinarycatheter 804 as the urinary catheter 804 is moved proximally withrespect to the protective sleeve tip 802. While FIG. 35 shows aprotective sleeve tip 802 having only one projection 812, it is withinthe scope of the present disclosure for a protective sleeve tip toinclude a plurality of projections, such as a number of projectionswhich is equal to the number of catheter eyes, with each catheter eyereceiving one of the projections. Additionally, while FIG. 35 shows aprotective sleeve tip 802 having a closed proximal end 806, with aprojection 812 extending into a catheter eye 814 defined in a lateralwall of a urinary catheter 804, it should be understood that theprotective sleeve tip 802 of FIG. 35 may be modified to include an openproximal end portion, with a projection that extends into a catheter eyeat the proximal end of the proximal end portion of a urinary catheter,similar to the protective sleeve tip 704″ of FIG. 34.

In the illustrated embodiment, the open distal end 808 of the protectivesleeve tip 802 is secured to a connecting member or funnel 816associated with the distal end portion 818 of the urinary catheter 804.Preferably, the open distal end 808 is sealed around an entire perimeterof the funnel 816 to fully shield the enclosed urinary catheter 804 fromthe outside environment. The urinary catheter 804 may be movedproximally with respect to the protective sleeve tip 802 by holding aportion of the protective sleeve tip 802 (e.g., a portion locatedbetween the proximal and distal ends 806 and 808) in place whilegripping the funnel 816 and then moving the funnel 816 proximally.Alternatively, the funnel 816 may be held in place while gripping aportion of the protective sleeve tip 802 and moving the protectivesleeve tip 802 distally. In another alternative, the funnel 816 may bemoved proximally while simultaneously gripping and moving the protectivesleeve tip 802 distally to unseat the projection 812 from the cathetereye 814 and move the proximal end portion 810 of the urinary catheter804 into contact with the proximal end 806 of the protective sleeve tip802, thereby moving the weakened section of the proximal end 806 to anopen condition.

In an alternative embodiment, the open distal end 808 of the protectivesleeve tip 802 may encircle the funnel 816 without being secured to thefunnel 816. In this case, a user may grip the distal end 808 of theprotective sleeve tip 802 and move it distally with respect to theurinary catheter 804 and funnel 816 to unseat the projection 812 fromthe catheter eye 814 and move the proximal end portion 810 of theurinary catheter 804 into contact with the proximal end 806 of theprotective sleeve tip 802, thereby moving the weakened section of theproximal end 806 to an open condition. In this embodiment, it may bepreferred for the opening of the open distal end 808 of the protectivesleeve tip 802 to be comparable in size to a perimeter of the funnel 816to ensure a tight or close fit between the protective sleeve tip 802 andthe funnel 816, which better shields the urinary catheter 804 from theoutside environment.

According to a method of using the urinary catheter assemblies describedherein, the protective tip is held in one hand, with the funnel at thedistal end of the catheter being held in the other. The hand holding theprotective tip guides it into the urethra, and then the other hand maybe used to move the funnel proximally with respect to the protectivetip, thereby moving the proximal end of the catheter out of theprotective tip and into the urethra. If practicing such a method ofusage, it may be preferred to employ a urinary catheter assembly havinga relatively rigid catheter, as described above, so that the catheterhas sufficiently column strength to disengage from or overcome thefrictional forces applied by the protective tip and move through theurethra without collapsing or buckling before the proximal end of thecatheter reaches the bladder. It may also be advantageous for thecatheter to have sufficient torsional strength to transmit a rotationalforce applied at the distal end to the proximal end, if the protectivetip is configured to be disassociated from the catheter upon rotationalmovement of the catheter, as described above.

Additional Aspects and Implementations

Aspects of the present subject matter described above may be beneficialalone or in combination with one or more other aspects. Without limitingthe foregoing description, in accordance with one aspect of the subjectmatter herein, there is provided a protective tip for use in combinationwith a urinary catheter of the type having at least one eye. Theprotective tip includes a generally tubular body portion defining aninterior cavity and at least one projection extending into the interiorcavity of the body portion. The projection is configured to be at leastpartially received by an eye of a urinary catheter at least partiallypositioned within the body portion.

In accordance with another aspect which may be used or combined with thepreceding aspect, the projection includes an inclined surface configuredto be at least partially received by an eye of a urinary catheter atleast partially positioned within the body portion.

In accordance with another aspect which may be used or combined with thepreceding aspect, the body portion extends between a distal end and aproximal end and the inclined surface of the projection faces theproximal end.

In accordance with another aspect which may be used or combined with anyof the preceding aspects, the projection includes a radial surfacefacing the proximal end and configured to be at least partially receivedby an eye of a urinary catheter at least partially positioned within thebody portion.

In accordance with another aspect which may be used or combined with anyof the preceding aspects, the projection extends generally radiallyinwardly from the body portion.

In accordance with another aspect which may be used or combined with anyof the preceding aspects, the projection is integrally formed with thebody portion.

In accordance with another aspect which may be used or combined with anyof the preceding aspects, an insert is associated with the body portion,with the projection extending from the insert.

In accordance with another aspect which may be used or combined with thepreceding aspect, the insert is fully received within the interiorcavity of the body portion.

In accordance with another aspect which may be used or combined with anyof the preceding two aspects, the insert further includes a guideconfigured to orient the projection with respect to an eye of a urinarycatheter at least partially positioned within the body portion.

In accordance with another aspect which may be used or combined with anyof the preceding aspects, a second projection extending into theinterior cavity of the body portion and configured to be at leastpartially received by a second eye of a urinary catheter at leastpartially positioned within the body portion.

In accordance with another aspect which may be used or combined with anyof the first six aspects, the protective tip is comprised of a proximalpiece and a distal piece.

In accordance with another aspect which may be used or combined with thepreceding aspect, the distal piece includes a fixed portion secured tothe proximal piece, a free portion positioned distally of the fixedportion, and a frangible portion positioned between the fixed and freeportions and configured to be broken to separate the fixed and freeportions.

In accordance with another aspect which may be used or combined with theeleventh aspect, the protective tip is comprised of a proximal piece anda separate distal piece.

In accordance with another aspect, there is provided a protective tipfor use in combination with a urinary catheter. The protective tipincludes a generally tubular body portion defining an interior cavityand at least one projection extending into the interior cavity of thebody portion. The projection is configured to apply a generally uniformfrictional force to an outer surface of a urinary catheter at leastpartially positioned within the body portion during use of theprotective tip and the urinary catheter.

In accordance with another aspect which may be used or combined with thepreceding aspect, a plurality of projections extend into the interiorcavity of the body portion and are configured to apply a generallyuniform frictional force to an outer surface of a urinary catheter atleast partially positioned within the body portion during use of theprotective tip and the urinary catheter.

In accordance with another aspect which may be used or combined with thepreceding aspect, the plurality of projections are substantiallyidentical.

In accordance with another aspect which may be used or combined with anyof the preceding three aspects, the projection is configured to besubstantially stationary during use of the protective tip and urinarycatheter.

In accordance with another aspect which may be used or combined with anyof the preceding four aspects, an insert associated with the bodyportion, wherein the at least one projection extends from the insert.

In accordance with another aspect which may be used or combined with thepreceding aspect, the insert is fully received within the interiorcavity of the body portion.

In accordance with another aspect which may be used or combined with anyof the fourteenth through seventeenth aspects, the protective tip iscomprised of a proximal piece and a distal piece.

In accordance with another aspect, there is provided a urinary catheterassembly including a protective tip, a urinary catheter, and a tether.The urinary catheter extends between proximal and distal ends, with itsproximal end being at least partially receivable within the protectivetip. The tether extends between the protective tip and the distal end ofthe urinary catheter.

In accordance with another aspect which may be used or combined with thepreceding aspect, a funnel is associated with the distal end of theurinary catheter, with the tether extending between the protective tipand the funnel.

In accordance with another aspect which may be used or combined with anyof the preceding two aspects, the protective tip includes an open distalend, with the tether being configured to prevent removal of the proximalend of the urinary catheter from the open distal end of the protectivetip without bending the urinary catheter.

In accordance with another aspect which may be used or combined with anyof the preceding three aspects, a plurality of tethers extend betweenthe protective tip and the distal end of the urinary catheter.

In accordance with another aspect, there is provided a urinary catheterassembly, which includes a urinary catheter and a protective tipreceived on the urinary catheter. The protective tip includes a proximalpiece and a distal piece, with the distal piece being separate from ordetachably connected to the proximal piece.

In accordance with another aspect which may be used or combined with thepreceding aspect, the distal piece of the protective tip is associatedwith a distal end of the urinary catheter prior to use.

In accordance with another aspect which may be used or combined with thepreceding aspect, the distal end of the urinary catheter includes afunnel, with the distal piece of the protective tip being detachablyconnected to the funnel prior to use.

In accordance with another aspect which may be used or combined with thepreceding aspect, the proximal piece of the protective tip is detachablyconnected to the distal piece prior to use, the proximal and distalpieces of the protective tip are movable along the urinary catheter fromthe distal end of the urinary catheter to a proximal end of the urinarycatheter, and the distal piece is configured to be detached from theproximal piece when the proximal piece has been moved to the proximalend of the urinary catheter.

In accordance with another aspect which may be used or combined with thetwenty-seventh aspect, the proximal piece of the protective tip isseparate from the distal piece and associated with a proximal end of theurinary catheter prior to use.

In accordance with another aspect which may be used or combined with thetwenty-fifth aspect, the urinary catheter extends between proximal anddistal ends, the proximal piece of the protective tip is associated withthe proximal end of the urinary catheter prior to use, and the distalpiece of the protective tip is separate from the proximal piece andpositioned between the proximal and distal ends of the urinary catheterprior to use.

In accordance with another aspect, there is provided a protective tipfor use in combination with a urinary catheter having a proximalextension with an enlarged end and a necked-down section positionedadjacent to and distally of the enlarged end. The protective tipincludes an outer member and an insert at least partially receivedwithin the outer member. The insert includes a generally radiallyinwardly extending projection configured to be positioned distally ofthe enlarged end of the urinary catheter and to contact the enlarged endof the urinary catheter to resist distal movement of the urinarycatheter with respect to the protective tip.

In accordance with another aspect which may be used or combined with thepreceding aspect, the projection is generally annular.

In accordance with another aspect which may be used or combined with anyof the preceding two aspects, the projection is hingedly associated withthe remainder of the insert.

In accordance with another aspect, there is provided a urinary catheterassembly, which includes a urinary catheter and a protective sleeve tip.The urinary catheter includes a proximal end portion defining at leastone eye. The protective sleeve tip is formed of a thin film material anddefines an interior cavity receiving the proximal end portion of theurinary catheter. The protective sleeve tip includes at least oneprojection extending into the interior cavity and at least partiallyreceived by the eye of the urinary catheter.

In accordance with another aspect which may be used or combined with thepreceding aspect, the urinary catheter assembly includes a distal pieceassociated with the protective sleeve tip, with the distal piece beingcomprised of a molded material.

In accordance with another aspect which may be used or combined with thepreceding aspect, the protective sleeve tip is comprised of apolyurethane material and the distal piece is comprised of a polyvinylchloride material.

In accordance with another aspect which may be used or combined with thethirty-fourth aspect, the urinary catheter is fully received within theprotective sleeve tip.

In accordance with another aspect which may be used or combined with anyof the preceding four aspects, the projection comprises a portion of thethin film material detachably connected to the urinary catheter.

In accordance with another aspect which may be used or combined with anyof the preceding five aspects, the eye is defined in a lateral wall ofthe proximal end portion of the urinary catheter.

In accordance with another aspect which may be used or combined with anyof the thirty-fourth through thirty-eighth aspects, the eye is definedin a proximal end of the proximal end portion of the urinary catheter.

It will be understood that the embodiments described above areillustrative of some of the applications of the principles of thepresent subject matter. Numerous modifications may be made by thoseskilled in the art without departing from the spirit and scope of theclaimed subject matter, including those combinations of features thatare individually disclosed or claimed herein. For these reasons, thescope hereof is not limited to the above description but is as set forthin the following claims, and it is understood that claims may bedirected to the features hereof, including as combinations of featuresthat are individually disclosed or claimed herein.

1-13. (canceled)
 14. A urinary catheter assembly, comprising: a urinarycatheter including a proximal end portion defining at least one eye; anda protective sleeve tip defining an interior cavity receiving theproximal end portion of the urinary catheter, wherein the protectivesleeve tip is formed of a thin film material and includes at least oneprojection extending into the interior cavity and at least partiallyreceived by the at least one eye of the urinary catheter.
 15. Theurinary catheter assembly of claim 14, further comprising a distal pieceassociated with the protective sleeve tip, wherein the distal piece iscomprised of a molded material.
 16. The urinary catheter assembly ofclaim 15, wherein the protective sleeve tip is comprised of apolyurethane material and the distal piece is comprised of a polyvinylchloride material.
 17. The urinary catheter assembly of claim 14,wherein the urinary catheter is fully received within the protectivesleeve tip.
 18. The urinary catheter assembly of claim 14, wherein theat least one projection comprises a portion of the thin film materialdetachably connected to the urinary catheter.
 19. The urinary catheterassembly of claim 14, wherein the at least one eye is defined in alateral wall of the proximal end portion of the urinary catheter. 20.The urinary catheter assembly of claim 14, wherein the at least one eyeis defined in a proximal end of the proximal end portion of the urinarycatheter. 21-40. (canceled)
 41. The urinary catheter assembly of claim15, wherein the at least one projection extends from the distal piece tobe at least partially received by the at least one eye of the urinarycatheter.
 42. The urinary catheter assembly of claim 14, furthercomprising a distal piece associated with the protective sleeve tip,wherein said urinary catheter defines first and second eyes, said atleast one projection comprises a first projection comprising a portionof the protective sleeve tip and at least partially received by thefirst eye and a second projection extending from the distal piece and atleast partially received by the second eye, and the protective sleevetip and the distal piece are formed of different materials.
 43. Theurinary catheter assembly of claim 20, further comprising an annularseal between the projection and an inner surface of the urinarycatheter.
 44. The urinary catheter assembly of claim 20, wherein theprotective sleeve tip includes an open proximal end at least partiallyreceived by the at least one eye of the urinary catheter.
 45. Theurinary catheter assembly of claim 20, wherein the protective sleeve tipincludes a closed proximal end at least partially received by the atleast one eye of the urinary catheter.
 46. A method of manufacturing aurinary catheter assembly, comprising: providing a urinary catheterincluding a proximal end portion defining at least one eye; positioningthe proximal end portion of the urinary catheter within a protectivesleeve tip at least partially formed of a thin film material; advancinga portion of the thin film material into the at least one eye of theurinary catheter; and detachably connecting said portion of the thinfilm material to an inner surface of the urinary catheter.
 47. Themethod of claim 46, further comprising providing the protective sleevetip with an associated distal piece formed of a different material thanthe protective sleeve tip.
 48. The method of claim 47, wherein saidproviding a urinary catheter includes providing a urinary catheterincluding a proximal end portion defining a first eye and a second eye,said providing a protective sleeve tip includes providing a distal piececomprising a projection, said advancing a portion of the thin filmmaterial into the eye of the at least one eye of the urinary catheterincludes advancing said portion of the thin film material into the firsteye, and further comprising advancing a portion of the projection of thedistal piece into the second eye.
 49. The method of claim 47, whereinthe thin film material is comprised of a polyurethane material and thedistal piece is comprised of a polyvinyl chloride material.
 50. Themethod of claim 46, wherein said providing a urinary catheter includesproviding a urinary catheter comprising a shaft extending between saidproximal end portion and a distal end portion, with a funnel associatedwith said distal end portion, and said positioning the proximal endportion of the urinary catheter within a protective sleeve tip includespositioning the entire catheter shaft within the protective sleeve tip.51. The method of claim 50, further comprising sealing the protectivesleeve tip to the funnel of the urinary catheter.
 52. The method ofclaim 46, wherein the at least one eye is defined in a lateral wall ofthe proximal end portion of the urinary catheter.
 53. The method ofclaim 46, wherein the at least one eye is defined in a proximal end ofthe proximal end portion of the urinary catheter.